FDA orders study, label for Essure

Posted at 7:42 PM, Feb 29, 2016
and last updated 2016-02-29 19:42:17-05

The Food and Drug Administration (FDA) announced Monday it will require the manufacturer of a controversial birth control device to conduct a clinical study and alter its warning label.

NewsChannel 5 Investigators have reported on problems with Essure for more than three years.

Today's announcement comes five months after an FDA panel hearing in Washington D.C.  where women from around the country testified about the serious side effects of the permanent birth control device.

The panel was convened after more than 5,000 women filed formal complaints with the FDA about complications, including bloating, bleeding, fatigue, miscarriages, ectopic pregnancies, and perforation of the fallopian tubes.

According to FDA spokesperson Deborah Kotz, "The agency intends to require a boxed warning and Patient Decision checklist be added to the product labeling to help to ensure that a woman receives and understands information regarding the benefits and risks of this type of device."

Bayer, which manufactures the device, will have 30 days from Monday to submit its plan to study Essure's risks to the FDA.

"The FDA must approve Bayer’s plan before the study can begin. Bayer has 15 months after the day on which FDA issues the order to begin their study. The FDA will work with Bayer to ensure that it designs and begins its postmarket surveillance study as quickly as possible," according to Kotz.

The FDA stopped short of pulling Essure off the market.

According to Kotz, "After significant review and analysis of available information, we believe Essure is safe and effective for many women – but also that some women experience very serious and sometimes debilitating problems."

In a statement, Kotz also wrote, "Banning Essure would remove the device from the market for all patients—and would limit the options available to physicians and patients. The FDA will continue to consider regulatory options that appropriately balance benefits and risks for the Essure device."

NewsChannel 5 Investigators reached out to Bayer for comment.

The company issued a news release. It said, in part: "Bayer will continue to work with the FDA to implement measures to support the continued safe, effective and appropriate use of Essure."

“Patient safety and appropriate use of Essure are our greatest priorities,” said Dario Mirski, M.D., senior vice president and head of medical affairs Americas at Bayer. “A woman’s decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure.”